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Regulatory issues in developing new HIV protease inhibitors: risks and benefits

Struble, Kimberly Aa; Chan-Tack, Kirk Ma; Soon, Guoxing (Greg)b

Current Opinion in HIV and AIDS: November 2008 - Volume 3 - Issue 6 - p 676–680
doi: 10.1097/COH.0b013e3283136cb1
HIV protease inhibitors: Edited by Jon Schapiro and John Erickson

Purpose of review To provide a regulatory perspective on developing new HIV protease inhibitors. The present review highlights the risks and benefits of certain design aspects for studies in treatment-naïve and treatment-experienced patients, including timing of studies, study design options, choice of control arms, and duration of treatment.

Recent findings The present review highlights published studies to illustrate the need for new therapies and highlights potential historical data to help design future HIV clinical trials better.

Summary New antiretroviral agents for patients with multidrug resistance, including safer, more convenient therapies without significant drug–drug interactions, are still needed for all patients. The goals of therapy have evolved and the expectation for treatment regimens is that the majority of patients, including treatment-experienced patients, will achieve undetectable HIV RNA. New study designs, particularly for treatment-experienced patients, are needed to help identify potential risks and benefits of new treatments.

aOffice of New Drugs, Office of Antimicrobial Products, Division of Antiviral Products, US Food and Drug Administration, USA

bOffice of Biostatistics, Division of Biometrics IV, US Food and Drug Administrations, Silver Spring, Maryland, USA

Correspondence to Kimberly Struble, 10903 New Hampshire Avenue, Building 22, Room 6347, Silver Spring, MD 20993, USA Tel: +1 301 796 1500; e-mail: Kimberly.struble@fda.hhs.gov

© 2008 Lippincott Williams & Wilkins, Inc.